MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES GELPOINT V-PATH; CULDOSCOPE (AND ACCESSORIES)

Model Number	C2A12
Medical Device Problem Code	Installation-Related Problem (2965)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned for evaluation and no lot number has been provided to applied medical.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: hysterectomy, bso, usls.Event description: for this case vnotes was performed post hysterectomy as the patient had severe prolapse.The v-path was placed to perform the bso/usls portion of the procedure.Upon laparoscopic entry, the surgeon visualized the right fallopian tube covered by the alexis sheath.The aps present at the case verified that the surgeon did perform a tissue sweep after placing the device and prior to starting the laparoscopic portion of the procedure.The surgeon used laparoscopic graspers to expose the tube.There was no patient injury as a result of entrapment and no further issues throughout the case.The case was successfully completed via vnotes.Summary: vnotes post hyst, tissue entrapment.Additional information provided on 06jan2025 by [name].There was internal tissue entrapment.Yes, the surgeon performed a tissue sweep before and after rolling down the alexis to check for tissue entrapment.Yes, the tissue sweep was done for both inner and outer ring of alexis.The surgeon resolved the issue by using a grasper to get the tube out from underneath the sheath.No, there were no challenges with the patient's anatomy.There was no patient injury caused by tissue entrapment.A grasper was used to get the tube out from underneath the sheath.Intervention: ni.Patient status: there was no patient injury as a result of entrapment and no further issues throughout the case.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.However, the customer¿s experience of tissue entrapment was confirmed based on the event description.Based on the description of the event, it is possible that a finger tissue sweep was not sufficient to discern that tissue was entrapped.Applied medical has performed a historical trend analysis and review of production records and no relevant documentations were identified.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.
Event or Problem Description
Procedure performed: hysterectomy, bso, usls.Event description: for this case vnotes was performed post hysterectomy as the patient had severe prolapse.The v-path was placed to perform the bso/usls portion of the procedure.Upon laparoscopic entry, the surgeon visualized the right fallopian tube covered by the alexis sheath.The aps present at the case verified that the surgeon did perform a tissue sweep after placing the device and prior to starting the laparoscopic portion of the procedure.The surgeon used laparoscopic graspers to expose the tube.There was no patient injury as a result of entrapment and no further issues throughout the case.The case was successfully completed via vnotes.Summary: vnotes post hyst, tissue entrapment.Additional information provided on 06jan2025 by [name].There was internal tissue entrapment.Yes, the surgeon performed a tissue sweep before and after rolling down the alexis to check for tissue entrapment.Yes, the tissue sweep was done for both inner and outer ring of (b)(6).The surgeon resolved the issue by using a grasper to get the tube out from underneath the sheath.No, there were no challenges with the patient's anatomy.There was no patient injury caused by tissue entrapment.A grasper was used to get the tube out from underneath the sheath.Intervention: ni.Patient status: there was no patient injury as a result of entrapment and no further issues throughout the case.

• Brand Name: GELPOINT V-PATH
• Common Device Name: CULDOSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: ashleigh mendez ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135359
• MDR Report Key: 21260768
• Report Number: 2027111-2025-00333
• Device Sequence Number: 15809949
• Product Code: HEW
• UDI-Device Identifier: 00607915138660
• UDI-Public: (01)00607915138660
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K191294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: C2A12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/28/2025
• Supplement Report FDA Received Date: 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GRASPER
• Patient Sex: Unknown